Airlife™ - Infant Skin Temperature Probe, Reusable - VYAIRE MEDICAL, INC.

Duns Number:080456871

Device Description: Infant Skin Temperature Probe, Reusable

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More Product Details

Catalog Number

6600-0628-700

Brand Name

Airlife™

Version/Model Number

6600-0628-700

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FMT

Product Code Name

WARMER, INFANT RADIANT

Device Record Status

Public Device Record Key

756254a6-7b6d-4a20-9cc4-57160f5d4ec4

Public Version Date

March 17, 2021

Public Version Number

1

DI Record Publish Date

March 09, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VYAIRE MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1068
2 A medical device with a moderate to high risk that requires special controls. 780
3 A medical device with high risk that requires premarket approval 65
U Unclassified 1